CDRH’s Regulatory Agenda for 2007-2008. Timothy A. Ulatowski Director, Medical Device Compliance, FDA March 28, 2007. Agenda Topics. Big challenges next fiscal year What is the coming (compliance and) enforcement agenda How can you influence the (enforcement) process?
Timothy A. Ulatowski
Director, Medical Device Compliance, FDA
March 28, 2007
*not a disclaimer
CDRH is committed to improving its medical device safety program.
CDRH’s Postmarket Transformation report provides a roadmap to transform our postmarket safety program and increase our ability to identify, analyze, and act on the risks that may be posed by the thousands of devices once they are in the real world.
Create a matrix structure across CDRH’s existing organizational structure to better link premarket, postmarket and enforcement efforts.
Enhanced data input, mining, analysis and tracking will help to improve the quality of care for patients by reducing medical errors, facilitating device recalls, and predicting clinical risk.
CDRH should be a trusted, publicly identifiable source for safety information about medical devices and radiation-emitting products.
Increased collaboration among CDRH, the Office of Regulatory Affairs, and the Office of Chief Counsel.
*FDLI **The Brookings Institute
“Strategic planning helps us achieve our mission and establish a vision for the future.”
Dr. Kessler will address